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Superficial Cervical Plexus Block for Postoperative Chronic Pain

Primary Purpose

Neurosurgery

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Superficial cervical plexus block
Control group
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurosurgery focused on measuring Cervical Plexus Block, Chronic pain, Neurosurgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Elective suboccipital retrosigmoid approach approach craniotomy;
  2. Age between 18 and 65 years;
  3. American Society of Anesthesiologists (ASA) physical status I-III.

Exclusion Criteria:

  1. The patients or legal clients refuse to provide informed consent;
  2. Local infection;
  3. Preoperative impairment of consciousness and cognitive function;
  4. Uncontrolled hypertension;
  5. Inability to communicate;
  6. Allergies to experimental drugs;
  7. History of drug abuse;
  8. History of chronic headache;
  9. Aphasia and hearing impairment;
  10. Patients undergoing second craniotomy;
  11. Body mass index < 18.5 kg/m2 or > 35.0 kg/m2;

Sites / Locations

  • Beijing Tian Tan Hospital, Capital Medical UniversityRecruiting
  • Beijing Tiantan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Scpb group

Control group

Arm Description

Superficial cervical plexus block group

Saline group

Outcomes

Primary Outcome Measures

Chronic pain assessment
Follow-up visit will be conducted by telephone at 3 months after surgery.

Secondary Outcome Measures

Full Information

First Posted
October 21, 2021
Last Updated
July 4, 2022
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05108337
Brief Title
Superficial Cervical Plexus Block for Postoperative Chronic Pain
Official Title
Ultrasound Guided Superficial Cervical Plexus Block for Chronic Pain After Craniotomy Via Suboccipital Retrosigmoid Approach: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The incidence of postoperative chronic pain after craniotomy is high. Postoperative chronic pain seriously affects patient's quality of life. Compound local scalp nerve block is a good choice for analgesia after craniotomy. However, the scalp nerve block commonly cannot cover the area of suboccipital retrosigmoid approach craniotomy, leading to incomplete block. Superficial cervical plexus block (SCPB) is theoretically promising to solve the analgesia requirements of such surgical approach. At the same time, ultrasound guidance can not only accurately locate, ensure the effect of block and avoid accidental injury during puncture. The purpose of this study is to explore whether ultrasound-guided superficial cervical plexus block can safely and effectively reduce the incidence of chronic pain after craniotomy via suboccipital retrosigmoid approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurosurgery
Keywords
Cervical Plexus Block, Chronic pain, Neurosurgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Scpb group
Arm Type
Experimental
Arm Description
Superficial cervical plexus block group
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Saline group
Intervention Type
Procedure
Intervention Name(s)
Superficial cervical plexus block
Intervention Description
Ultrasound guidance will be used to determine the location of superficial cervical plexus nerve. The puncture will also be performed by ultrasound guidance, covered with opaque infusion dressing but performed with infusion of 10 ml 0.5% ropinacaine.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Ultrasound guidance will be used to determine the location of superficial cervical plexus nerve. The puncture will also be performed by ultrasound guidance, covered with opaque infusion dressing but performed with infusion of 10 ml normal saline.
Primary Outcome Measure Information:
Title
Chronic pain assessment
Description
Follow-up visit will be conducted by telephone at 3 months after surgery.
Time Frame
at 3 months after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Elective suboccipital retrosigmoid approach approach craniotomy; Age between 18 and 65 years; American Society of Anesthesiologists (ASA) physical status I-III. Exclusion Criteria: The patients or legal clients refuse to provide informed consent; Local infection; Preoperative impairment of consciousness and cognitive function; Uncontrolled hypertension; Inability to communicate; Allergies to experimental drugs; History of drug abuse; History of chronic headache; Aphasia and hearing impairment; Patients undergoing second craniotomy; Body mass index < 18.5 kg/m2 or > 35.0 kg/m2;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuming Peng, M.D.
Phone
8610-59976658
Email
florapym766@163.com
Facility Information:
Facility Name
Beijing Tian Tan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuming Peng
Phone
8610-59976658
Email
florapym766@163.com
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuming Peng, M.D.,PhD.
Phone
861059976658
Email
florapym766@163.com

12. IPD Sharing Statement

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Superficial Cervical Plexus Block for Postoperative Chronic Pain

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